Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lamictal · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Lamotrigine | EXPERIMENTAL | Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period |
| Lamictal® | ACTIVE_COMPARATOR | Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Lamotrigine | DRUG | 200 mg Tablet |
| Lamictal® | DRUG | 200 mg Tablet |
Inclusion Criteria * Subjects will be females and/or males, non-smokers, 18 years of age and older. * Female Subjects will be post-menopausal or surgically sterilized. * Post-menopausal status is defined as absence of menses for the past 12 months, * Sterile status is defined as hysterectomy, bilat...
Lamictal, also known as lamotrigine, is being studied in healthy volunteers in Phase 1 clinical trials. These trials are bioequivalence studies of a 200 mg lamotrigine tablet under fasting and non-fasting conditions. The drug is not approved for any specific indication based on the available data.
Lamictal is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the bioequivalence of a 200 mg lamotrigine tablet in healthy volunteers.
Lamictal is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers for bioequivalence purposes. It has not been approved by regulatory authorities, and it remains in early-stage clinical trials.
Lamictal is involved in two completed Phase 1 clinical trials: NCT00834561, a bioequivalence study of a 200 mg lamotrigine tablet under fasting conditions, and NCT00835263, a similar study under non-fasting conditions. Both trials enrolled 32 healthy volunteers each in Canada.
Yes, Lamictal is the brand name for lamotrigine. The clinical trials for Lamictal are specifically studying a 200 mg lamotrigine tablet, confirming that Lamictal and lamotrigine refer to the same drug substance.